Novartis has resubmitted to the US Food and Drug Administration (FDA) its new drug application (NDA) for inclisiran, a potential blockbuster drug for treating certain types of high cholesterol, to reflect a change to the manufacturing site for the drug. Novartis is listing its own site in Schaftenau, Austria, as the manufacturing location for the final finished product in the resubmission.

Novartis gained inclisiran as part of its $9.7-billion acquisition of The Medicines Company in 2020. The drug is slated by some analysis as a potential blockbuster (defined as sales of $1 billion or more).

In December 2019, The Medicines Company submitted a NDA for inclisiran to the FDA for use in secondary prevention for patients with atherosclerotic cardiovascular disease and familial hypercholesterolaemia, an inherited disorder that results in high levels of low-density lipoprotein cholesterol. Inclisiran is a small-interfering RNA drug and PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor.

The FDA issued a Complete Response Letter (CRL) in December 2020 and cited unresolved facility inspection-related conditions at a third-party manufacturing facility. The FDA did not raise any concerns related to the efficacy or safety of inclisiran. Novartis says the transfer of the manufacturing of inclisiran to the Novartis-owned facility at Schaftenau, Austria was planned and initiated in 2020, prior to the receipt of the CRL.

Novartis says it will provide an update after the FDA has determined that the response resubmission is complete.

Source: Novartis